A new Observation Index is now available. This document refers to the relevant provisions in Directive 2001/83/CE and in the EFPIA HCP Code, as amended in June 2013. Modifications are based on input from EFPIA membership and those stakeholders of the pharmaceutical industry that are included in the pre-assessment process of scientific and professional events with regard to EFPIA HCP Code provisions. Pre-assessments dated March 25th, 2015 onwards shall be based on this new Observations Index. (Click here to see its previous version)

EFPIA and itsmembers are conscious of the importance of providing accurate, fair and objective information about medicinal products so that rational decisions can be made as to their use. The EFPIA Code on the Promotion of prescription-only medicines to, and interactions with, Healthcare Professionals – the EFPIA HCP Code– fits into the general framework established by theEU Directive 2001/83/EC(Title VIII & Title VIIIa – p. 49 to 54), including provisions on the information and advertising of medicines. The EFPIA HCP Code seeks to ensure that pharmaceutical companies conduct such promotion and interactions with prescribers in a truthful manner, avoiding deceptive practices and potential conflicts of interest with healthcare professionals, and in compliance with applicable laws and regulations.

HCP includes any member of the medical, dental, pharmacy or nursing professions or any other person who in the course of his/her professional activities may prescribe, purchase, supply or administer a medicinal product.

Any practice that might create confusion about the real scientific and educational purpose of scientific events sponsored by industry or to which industry sponsors HCPs should not be tolerated.

Article 10 of the EFPIA HCP Code provides that:

Section 10.01. All promotional, scientific or professional meetings, congresses, conferences, symposia, and other similar events (including, but not limited to, advisory board meetings, visits to research or manufacturing facilities, and planning, training or investigator meetings for clinical trials and non-interventional studies) (each, an “event”) organised or sponsored by or on behalf of a company must be held in an “appropriate” venue that is conducive to the main purpose of the event and may only offer hospitality when such hospitality is appropriate and otherwise complies with the provisions of any Applicable Code(s).

Section 10.02. No company may organise or sponsor an event that takes place outside its home country unless:

(a) most of the invitees are from outside of its home country and, given the countries of origin of most of the invitees, it makes greater logistical sense to hold the event in another country; or

(b) given the location of the relevant resource or expertise that is the object or subject matter of the event, it makes greater logistical sense to hold the event in another country (an “international event”).

Section 10.03. Promotional information which appears on exhibition stands or is distributed to participants at international events may, unless prohibited or otherwise regulated by local laws and regulations, refer to medicinal products (or uses) which are not registered in the country where the event takes place, or which are registered under different conditions, so long as (i) any such promotional material (excluding promotional aids) is accompanied by a suitable statement indicating countries in which the product is registered and makes clear that the product or use is not registered locally, and (ii) any such promotional material which refers to the prescribing information (indications, warnings etc.) authorized in a country or countries where the medicinal product is registered should be accompanied by an explanatory statement indicating that registration conditions differ internationally.

Section 10.05. Member Companies shall not provide or offer any meal (food and beverages) to healthcare professionals, unless, in each case, the value of such meal (food and beverages) does not exceed the monetary threshold set by the relevant Member Association in its national code. Each Member Association shall set such monetary threshold in its national code by 31 December 2013, failing which EFPIA will set such threshold in lieu of such Member Association. The monetary threshold set in the country where the event takes place (i.e. the “host country”) shall prevail, as an exception to the provision of Article 13.01 and deviating from the general principle where the strictest prevails (as set out in the Applicable Codes section.

Section 10.06. Hospitality may only be extended to persons who qualify as participants in their own right.

Section 10.07. All forms of hospitality offered to healthcare professionals shall be “reasonable” in level and strictly limited to the main purpose of the event. As a general rule, the hospitality provided must not exceed what healthcare professional recipients would normally be prepared to pay for themselves.

Section 10.08. Hospitality shall not include sponsoring or organising entertainment (e.g., sporting or leisure) events. Companies should avoid using venues that are “renowned” for their entertainment facilities or are “extravagant”.

Section 10.09. Member associations shall provide guidance on the meaning of the term “reasonable”, as used in this Article 10. Member associations shall also provide guidance on “appropriate”, “renowned” and “extravagant” venues, as used in Section 10.01 and Section 10.08. Companies must comply with any relevant guidance provided under this Section 10.09 in connection with any Applicable Code(s).